NDC 16729-045-01 - ATORVASTATIN CALCIUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 16729-045
Requested NDC: 16729-045-01
Package NDCs from labels: 16729-045-10, 16729-045-15, 16729-045-01, 16729-045-16, 16729-045-17
Manufacturer: Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date: 2025-10-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ATORVASTATIN CALCIUM - Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-10-06	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-10-31	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2023-03-31	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-03	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Proficient Rx LP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Quality Care Products, LLC	Quality Care Products, LLC	2021-09-22	HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-06-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-045-01	ATORVASTATIN CALCIUM	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
16729-045-10	ATORVASTATIN CALCIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
16729-045-15	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90	13
16729-045-16	ATORVASTATIN CALCIUM	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
16729-045-17	ATORVASTATIN CALCIUM	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-045	ATORVASTATIN CALCIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	12	Current NDC, Legacy NDC, 5 package rows	20241004_4e06b20d-cc5d-46eb-991b-5972248de3af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-045-15	EA - Each	16729-045	ec800b59-eb53-4816-ab9d-7ff42a9cb5ef	1	2021-06-02
16729-045-17	EA - Each	16729-045	d79f8df8-c45e-4468-97c7-9884a2fcd530	1	2018-08-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 144 of 144 · 2,869 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30	DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30	Mana Products	cec89a7e-1670-4d3c-b48c-28ed1ea7f957	2016-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
Age Renewal Firming	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	AMCOL Health & Beauty Solutions, Inc. DBA	6cb27f87-40a3-4049-aded-eb788509c575	2016-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	Mana Products	d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab	2016-09-08	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
Antacid Relief	CALCIUM CARBONATE	Safeway	ead5101d-761a-4d1d-b14b-4dd548d2def6	2016-01-22	Warnings	Exact identifier unii: H0G9379FGK
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.